PHARMExcel’s Quality Policy
Quality in everything we do is integral to all our working practices.
It is critical to the success of our business and our long-term sustainability and profitability.
PHARMExcel is a full-service Contract Research Organisation (CRO) providing Phase I-IV clinical research services to the academic, biopharma and medical device industry. As a leading CRO, PHARMExcel’s collaborative approach, knowledge and experience ensure it delivers quality results in the most efficient way to its clients and partners, regardless of study size or scope. PHARMExcel offers in-depth knowledge and experience of the UK clinical research industry and has a network of regulatory and other industry associates enabling a global reach.
PHARMExcel is committed to fostering a culture of quality, integrity, ethical behaviour, transparency, and continual improvement throughout the organisation, ensuring quality is embedded in all activities and decision-making processes.
PHARMExcel places particular emphasis on reliability and quality. PHARMExcel seeks to understand and meet the needs and expectations of its clients, employees, service providers, regulators, and other interested parties relevant to the success of the organisation and the effectiveness of its Quality Management System (QMS).
PHARMExcel conducts its activities in accordance with the principles of scientific integrity, data integrity, ethical conduct, and regulatory compliance.
PHARMExcel is dedicated towards maintaining the QMS and achieving and maintaining ISO 9001 certification. PHARMExcel endeavours continually to improve the effectiveness and implementation of the QMS and satisfy all applicable requirements relevant to the business.
PHARMExcel applies risk-based thinking and opportunity management throughout its business processes to support informed decision-making, service excellence, operational resilience, and continual improvement.
PHARMExcel considers relevant environmental, sustainability and climate-related factors that may affect the organisation, its stakeholders, and the effectiveness of the QMS.
To realise this commitment, PHARMExcel has established the following objectives as a cornerstone of the QMS:
For the business
- To comply consistently with the requirements of ISO 9001 and all legal & statutory requirements by continually seeking to improve the effectiveness of the QMS and overall performance.
- To develop a framework for establishing and reviewing Quality Objectives.
- To provide confidence to management and employees that the requirements for quality are being fulfilled and maintained, and that improvements in quality are continuously being delivered.
- To ensure sufficient resources are made available within the company to achieve this.
- To ensure through communication, engagement, practical examples and training that quality is the aim of all members of the company.
- To identify, assess and manage risks and opportunities that may affect quality, client satisfaction, regulatory compliance, and business performance.
- To manage organisational, operational, technological, and business changes in a planned and controlled manner to maintain quality, compliance, and business continuity.
- To promote and continually strengthen a culture of quality, accountability, integrity, and continual improvement throughout the organisation.
- To ensure organisational knowledge is identified, retained, shared, and applied to support operational excellence, innovation, and business sustainability.
For its clients
- To maintain the highest standards of ethical conduct, scientific integrity and data integrity throughout the planning, management, and delivery of services.
- To provide confidence to its clients that their requirements for quality are being achieved in the delivered service.
- To work closely with its clients to remedy any quality issues quickly and efficiently.
For its employees
- To maintain a healthy work environment that enables all employees to achieve their objectives and to foster open communication and engagement to encourage employees to raise quality/process improvements.
- To provide continuous training and development for employees in line with both PHARMExcel and employee needs.
- To encourage employees to contribute actively to quality culture, ethical behaviour, continual improvement, and risk-based thinking.
- To promote knowledge sharing, collaboration, and professional development to strengthen organisational capability and resilience.
- To ensure every employee has a proper understanding of the importance of the QMS, their responsibility to contribute to its effectiveness, and their accountability to its direct relevance to the success of the company.
- To ensure employees understand their role in maintaining quality culture, data integrity, compliance, and ethical conduct.
To achieve these objectives, it is the policy of PHARMExcel to review the suitability and effectiveness of the QMS and work processes on a consistent basis in conjunction with all managers and employees, whose contribution and input is seen as vital in the improvement and development of PHARMExcel. Reviews will consider organisational context, risks, interested party requirements, quality objectives, organisational knowledge, business changes, and opportunities for improvement.
The QMS and this policy is seen as essential for the long‐term success of PHARMExcel and will be communicated to all personnel through initial induction, meetings, ongoing development, and training to ensure continued adherence and compliance with requirements.
This policy is available to all employees and interested parties:
Externally
- On the PHARMExcel website.
Internally
- As a controlled document in the electronic QMS
- On display in the PHARMExcel office
- Upon request from the Quality Assurance department
This policy will be regularly reviewed by the Executive Leadership Team (ELT) and amended as appropriate. The ELT is accountable for promoting quality culture, ethical behaviour, risk-based thinking, client focus, and continual improvement, and for ensuring the QMS remains aligned with PHARMExcel’s strategic direction and business objectives.
POL-0000015 V3.0 28-Sep-2026